- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04228016
Efficacy of an Intranasal Stent on Nasal Obstruction at Night (RHINASTENT)
Efficacy of an Intranasal Stent on Nasal Obstruction at Night: A Prospective Multicenter Study
Study Overview
Detailed Description
All patients consulting for nasal obstruction at night and who have functional nasal test with pathological resistance in decubitus position are included.
Functional nasal test (non invasive tests) will be performed before and after intranasal introduction of a stent: anterior rhinomanometry to measure nasal function by the measure of resistance and acoustic rhinometry to measure the geometry of nasal fossa by the measure of minimal sectional cross area sitting, after 30 minutes of decubitus then new measurements with a stent in decubitus position in each nostril .
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jung Camille, MD
- Phone Number: 01.57.02.22.68
- Email: camille.jung@chicreteil.fr
Study Locations
-
-
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Créteil, France, 94000
- Not yet recruiting
- Hôpital Henri Mondor
-
Contact:
- Emilie BEQUIGNON
- Email: emilie.bequignon@gmail.com
-
-
Ile De France
-
Créteil, Ile De France, France, 94000
- Recruiting
- Centre Hospitalier Intercommunal
-
Contact:
- Emilie BEQUIGNON
- Email: emilie.bequignon@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Volontary patient
- Over 18 years old or more.
- Complain of a nasal obstruction more important (or only) at night (in decubitus position)
Exclusion Criteria:
- Unability to sign the consent form
- Allergy of stent component
- Perforation of nasal septum
- Haemostasis disorder or anticoagulant therapy
- Bilateral obstructive septal deviation ou polyposis induce inability to introduce the stent in the nasal cavities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Device : nasal airway stent
All patients consulting for predominantly nocturnal nasal obstruction who have benefited from Nasal Respiratory Functional Exploration with detection of pathological resistance in the decubitus.
|
Patients with Nasal obstruction at night, will be used intrasal stent during 15 nights.
These are flexible silicone tubes that are lubricated and easy to insert into the nasal cavities, which would restore the permeability of the nasal cavities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nasal resistance in anterior rhinomanometry (sPa/ml/sec)
Time Frame: Day 15
|
Change grom Baseline of Nasal resistance in anterior rhinomanometry.
Sitting, lying in the meadow and Per stent nasal.
|
Day 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nasal Obstruction and Septoplasty Effectiveness (NOSE)
Time Frame: Day 15
|
Scale [0-100] The higher the score, the more the quality of life is impaired.
|
Day 15
|
Analog visual scale (EVA) of nocturnal nasal obstruction
Time Frame: Day 15
|
Scale [0-10] The higher the score, the stronger the feeling of nasal obstruction.
|
Day 15
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Sino-Nasal Outcome Test 22 (SNOT-22) questionary
Time Frame: Day 15
|
Scale [0-100].
The total score can range from 0 to 110, with values increasing as the severity of symptoms worsens
|
Day 15
|
Epworth Sleepiness Scale (ESS)
Time Frame: Day 15
|
Scale [0-24] The higher the score, the more the quality of life is impaired.
|
Day 15
|
Compliance
Time Frame: Day 15
|
Questionnaire on the use or non-use of the stent
|
Day 15
|
Stent satisfaction
Time Frame: Day 15
|
Number of patients satisfied with the stent
|
Day 15
|
Stent tolerance
Time Frame: Day 15
|
Questionnaire on stent tolerance or non-tolerance
|
Day 15
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHINASTENT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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